DETAILED ACTION
The Examiner for this application has changed. Please direct all future correspondence to Examiner Jennifer Spence, Art Unit 1633. Additional contact information can be found at the end of this paper.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-21, of record 4/10/2026, are pending.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-9, in the reply filed on 4/10/2026 is acknowledged. Claims 1-9 are therefore subject to prosecution.
Claims 10-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/10/2026.
Priority
The instant application is a CIP of 16/805305 (US patent 11820988, filed 2/28/2020), which claims benefit of provisional application 62/811756 (filed 2/28/2019).
The applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) to provisional application ‘756 or parent application ‘305 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
A claim is only entitled to the effective filing date of a benefit or priority document if that document provides the claim with an enabling disclosure and adequate written description. 35 U.S.C. 119(e)(1); 35 U.S.C. 120; MPEP 1893.03(c), part (III); MPEP 2139.01 (pre-AIA ); MPEP 2152.01. As such, if a claim is correctly rejected under 35 U.S.C. 112(a) for lack of enablement or lack of adequate written description, it necessarily cannot be entitled to the filing dates of its benefit or priority documents. This may result in additional prior art being available, including published applications and patents from within the application’s own benefit chain. Determining the effective filing date of a claim is done on a claim-by-claim basis. Amendments to claims during prosecution can therefor affect the effective filing date of those claims. See MPEP 2152.01.
The disclosure of the prior-filed applications ‘756 and ‘305 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Independent claim 1 is drawn to a VLP comprising one or both of: (a) an OAS operatively linked with a BSMV-CP wherein a portion of the nucleic acid sequence that encodes the OAS comprises SEQ ID NO: 11 or a functional equivalent thereof, and (b) at least one site-directed mutation on the BSMV-CP at residue E62, D101, or both residues E62 and D101, wherein each site-directed mutation independently comprises a neutral or positive amino acid; wherein the VLP is stable at a pH of at or between about 4 to about 9.
Applications ‘756 and ‘305 fail to teach or suggest:
a) a VLP comprising the structural features of limitation (a) and/or (b) that is stable within the breadth of the claimed pH range. Suspension of VLPs in a pH 7 Tris buffer for TEM imaging is taught in the PG Pub for ‘305 (See ¶0118 of the PG Pub); however, stability at this pH is not discussed, and no data on the stability of VLPs at other pH values is provided;
b) a representative number of species encompassed by the genus of VLPs that would be predictably stable at a pH at or between about 4-9. While the ‘305 application teaches that strengthening the interaction between coat protein subunits can render VLPs less susceptible to pH extremes (See ¶0114 of the PG Pub), there is no discussion of how to predictably accomplish this, nor is there disclosure of VLPs comprising the claimed structural features that are predictably stable at pH 4-9. Further, there is no reduction to practice of pH stability determinations for any VLPs disclosed by either application. The ‘756 and ‘305 applications therefore do not fully support the claimed invention recited in independent claim 1 under 112(a). See MPEP 2152.01.
Because claims 2-9 are dependent upon claim 1, claims 2-9 are likewise not supported under 35 U.S.C. 112(a) in the ‘756 and ‘305 applications. Only the claims of a continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed applications are entitled to the benefit of the filing date of the prior-filed applications. See MPEP 211.05(B). VLP stability at the claimed pH range first appears in the instant application, filed 11/21/2023. As such, pending claims 1-9 are given a priority date of 11/21/2023.
Drawings
The drawings are objected to because view number must be preceded by the abbreviation “FIG.” See 37 CFR 1.84(u). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms BL21-CodonPlus, Lysonase, Zetasizer Nano, Phusion, AlphaFold, SpectraMax, Superdex, and NGC, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 7 is objected to because of the following informalities:
In line 1 of claim 7, “is” should be replaced with “are”.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites the limitation “wherein a portion of the nucleic acid sequence that encodes the OAS comprises SEQ ID NO: 11 or a functional equivalent thereof”. Consistent with ¶0127 of the instant application’s PG Pub, “a functional equivalent thereof” is interpreted as requiring a nucleic acid sequence that has greater than 40% homology with SEQ ID NO 11 and that has essentially the same properties, structure, and/or function.
Claim 1 also recites the limitation “stable”, which is not defined in the specification. The broadest reasonable interpretation of this limitation is therefore considered to be not exhibiting significant degradation, denaturation, and/or inactivation.
Claim 3 recites the limitation “wherein the site-directed mutation at residue E62 comprises SEQ ID NO: 9 or a functional variant thereof, the site-directed mutation at residue D101 comprises SEQ ID NO: 5 or 6, or a functional variant thereof, or the site-directed mutation at both residues E62 and D101 comprises SEQ ID NO: 10 or a functional variant thereof”. Consistent with ¶0127 of the instant application’s PG Pub, “a functional equivalent thereof” is interpreted as requiring an amino acid sequence that has greater than 40% homology with SEQ ID NO 5 or 6, 9, or 10 and that has essentially the same properties, structure, and/or function.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaidya et al. (Biochemical Engineering Journal, 2023), evidenced by Lee et al. (ACS Applied Nano Materials, 2020).
Vaidya et al. teach BSMV VLPs comprising coat protein modifications to enhance pH stability (See Abstract).
Regarding claims 1-2 and 4-9: Vaidya et al. teach BSMV coat proteins comprising E62Q, D101N, D101R, and/or D101K mutations (which reads on “each site-directed mutation independently comprises a neutral or positive amino acid”) (See table 1). The D101R mutant had an average rod length of 125 nm at pH 7 and 91 nm at pH 9 (which reads on “a rod length of at or between about 75 nm to about 150 nm”) and exhibited less fragmentation at pH 9 than wt BSMV VLPs (which reads on “stable at a pH of at or between about 4 to about 9”) (See page 6, col. 2, ¶1 and fig. 6). A lysine-encoding codon was inserted at the exposed coat protein C-terminus (which reads on “surface-exposed C-termini comprising a site-directed insertion of a natural amino acid”) and reacted with fluorescamine (which reads on “functionalized with a ligand” and “a fluorescent label”) (See page 2, col. 2, full ¶3 and fig. 9).
Regarding claim 3: Following the discussion of claims 1-2 and 4-9, Vaidya et al. do not expressly teach the coat protein sequences for the mutants. However, Vaidya et al. teach that the plasmid used for BSMV coat protein expression was disclosed by Lee et al. (See page 2, col. 2, full ¶3).
Lee et al. teach a coat protein coding sequence that yields an amino acid sequence that comprises a sequence identical to instant SEQ ID NOs 9, 5, and 10, except for point mutations at positions 62 and/or 101 (See S2 of Supporting Information and alignments below (first 120 aa displayed)).
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Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (ACS Applied Nano Materials, 2020).
Lee et al. teach BSMV VLPs as a template for palladium nanoparticles (See Abstract).
Regarding claim 1: Lee et al. teach VLPs produced by fusing the TMV origin of assembly to a nucleotide encoding the BSMV coat protein (which reads on “an origin of self-assembly… operatively linked with a Barley stripe mosaic coat protein”) (See fig. 3). The TMV origin of assembly consists of a sequence identical to instant SEQ ID NO 11 (which reads on “a portion of the nucleic acid sequence that encodes the OAS comprises SEQ ID NO: 11 or a functional equivalent thereof”) (See S2 of Supporting Information and alignment below (first 120 nt displayed)).
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The VLPs were stable in water and pH 7 Tris buffer (which reads on “the VLP is stable at a pH of at or between about 4 to about 9”) (See page 12082, col. 2, full ¶1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (ACS Applied Nano Materials, 2020).
The teachings of Lee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 4: Following the discussion of claim 1, Lee et al. teach that the VLPs yielded nanorod lengths ranging between 20-160 nm (which reads on “about 75 nm to about 150 nm”) (See page 12083, col. 1, full ¶1 and fig. 8). Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP 2159. See MPEP 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11820988, evidenced by Lee et al. (ACS Applied Nano Materials, 2020).
Regarding claims 1-3: Patented claim 1 recites a method of manufacturing a nanoparticle biotemplate comprising the steps of: introducing into an isolated host a nucleic acid sequence comprising SEQ ID NO: 1 or a functional equivalent thereof that encodes a Barley stripe mosaic virus coat protein (BSMV-CP), and one or both of: (a) an origin of self-assembly (OAS) of a Tobacco mosaic virus operatively linked with the BSMV-CP wherein a portion of the nucleic acid sequence that encodes the OAS comprises SEQ ID NO: 11 or a functional equivalent thereof, and (b) at least one site-directed mutation on the BSMV-CP that facilitates self-assembly of a BSMV viral-like particle by at least replacing a repulsive interaction between at least-two wild-type BSMV-CP subunits with a neutral or attractive interaction between the correlative at least two BSMV-CP subunits of the encoded BSMV-CP, wherein the at least one site-directed mutation on the BSMV-CP is: at residue E37Q and comprises SEQ ID NO: 7, at residue E37R and comprises SEQ ID NO: 8, at residue E62Q (which reads on “a neutral… amino acid”) and comprises SEQ ID NO: 9, at residue D68N and comprises SEQ ID NO: 2, at residue D70N and comprises SEQ ID NO: 3, at residue D101N (which reads on “a neutral… amino acid”) and comprises SEQ ID NO: 5, at residue D101R (which reads on “a… positive amino acid”) and comprises SEQ ID NO: 6, at residue D101K (which reads on “a… positive amino acid”) and comprises SEQ ID NO: 4, or a combination of site mutations comprising two or more of the foregoing; expressing the nucleic acid sequence in a microbial expression system to produce self-assembled BSMV viral-like particles (BSMV VLPs); and isolating the BSMV VLPs from the microbial expression system.
The method of patented claim 1 renders obvious VLPs having the claimed structural limitations as a product but does not expressly teach stability at pH 4-9. However, Lee et al. teach that VLPs comprising the BSMV coat protein and the TMV origin of assembly are stable in water and pH 7 Tris buffer (which reads on “the VLP is stable at a pH of at or between about 4 to about 9”) (See page 12082, col. 2, full ¶1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/JENNIFER S SPENCE/
Examiner, Art Unit 1633
Prosecution Insights